WARNINGS

PRECAUTIONS

Rate of Administration

Because of the Ca++ content of the levoleucovorin solution, no more
than 16 mL (160 mg of levoleucovorin ) should be injected intravenously per
minute.

Potential for Enhanced Toxicity with 5-Fluorouracil

levoleucovorin enhances the toxicity of 5-fluorouracil. Deaths from severe
enterocolitis, diarrhea, and dehydration have been reported in elderly patients
receiving weekly d,l-leucovorin and 5-fluorouracil.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No studies have been conducted to evaluate the potential of levoleucovorin
for carcinogenesis, mutagenesis and impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C. It is not known whether levoleucovorin can cause fetal
harm when administered to a pregnant woman or if it can affect reproduction
capacity. Animal reproduction studies have not been conducted with levoleucovorin.
levoleucovorin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when levoleucovorin
is administered to a nursing mother.